Bisphosphonates are a type of drug used to prevent and treat bone loss. The purpose of this study is to determine if zoledronate, an investigational bisphosphonate, can improve bone mineral density (BMD) in HIV-infected adults.

Participants will receive zoledronate at study entry; their assigned intervention will be given in a 20- to 30-minute infusion on an outpatient basis

Drug: Zoledronate

Zoledronate infusion

Placebo Comparator: 2

Participants will receive zoledronate placebo at study entry; their assigned intervention will be given in a 20- to 30-minute infusion on an outpatient basis

Drug: Zoledronate placebo

Zoledronate placebo infusion

Detailed Description:

Decreased BMD and bone loss is estimated to affect up to 67.5% of the HIV-infected population. HIV-associated bone loss may be a result of antiretroviral treatment (ART), but can also be caused by the infection itself. To date, treatment for this bone loss has not been established. Before prescribing drugs to treat bone loss, physicians must take into account patients' already demanding ART schedules and potential nonadherence. This study will evaluate the efficacy of a single IV dose of zoledronate, an investigational bisphosphonate, in treating HIV-associated bone loss.

This study will last 1 year. Participants will be randomly assigned to receive zoledronate or placebo at study entry; their assigned intervention will be given in a 20- to 30-minute infusion on an outpatient basis. There will be 7 study visits: at screening, study entry, Week 2, and Months 3, 6, 9, and 12. Blood collection will occur at all visits. Medical history, a physical exam, a dual-energy x-ray absorptiometry (DEXA) scan to measure bone density, and a nutrition evaluation will occur at selected visits.

Eligibility

Ages Eligible for Study:

18 Years to 70 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

HIV-infected

On stable antiretroviral regimen for at least 3 months

Able to walk

Lumbar spine or total hip BMD T-score at least 1.5 SD and no more than 3.5 SD below the mean BMD

No prevalent fractures at entry OR 1 prevalent vertebral fracture that has been asymptomatic during the last 2 years prior to study entry

HIV viral load of less than 5000 copies/ml within the 2 months prior to study entry

CD4 count of more than 100 cells/mm3 within the 2 months prior to study entry

Willing to use acceptable forms of contraception during the study period and for 6 months after study completion. Participants who are female and postmenopausal will be required to take hormone replacement therapy during this study.

Exclusion Criteria:

Prior treatment with bisphosphonates or fluoride

Use of supraphysiologic systemic estrogen/androgen therapy or corticosteroid therapy within the 3 months prior to study entry. Participants who have taken hormone replacement therapy are not excluded.

Significant liver or kidney disease

Hemoglobin less than 8 g/dL

Serum calcium less than 8 mg/dL

Laboratory evidence of low levels of estrogens or androgens

Laboratory evidence of overactive parathyroid glands

History of thyroid, parathyroid, or other endocrinologic disorder known to affect bone

Current use of any therapy known to affect bone

Current or history of cancer or chemotherapy

Current or history of radiotherapy to the jaw

Current osteomyelitis of the jaw or ongoing dental infection

Recent tooth extraction or major dental procedure within 3 weeks of study entry

Pregnancy or breastfeeding

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00102908